Consumer medicine information

Meropenem Ranbaxy

Meropenem

BRAND INFORMATION

Brand name

Meropenem Ranbaxy

Active ingredient

Meropenem

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Meropenem Ranbaxy.

What is in this leaflet

This leaflet answers some common questions about MEROPENEM RANBAXY.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking MEROPENEM RANBAXY against the benefits it is expected to have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What MEROPENEM RANBAXY is used for

MEROPENEM RANBAXY contains the active ingredient meropenem. Meropenem belongs to a group of medicines called carbapenem antibiotics. These medicines fight bacteria that cause infections in the body. Meropenem will not work against viral (such as colds and flu) or fungal diseases.

Your doctor may have prescribed MEROPENEM RANBAXY to you or your child (aged 3 months or above) for the treatment of the following bacterial infections:

  • Infections of the lungs (pneumonia or bronchitis)
  • Infections of the bladder or kidney (urinary tract infection)
  • Infection of tissues around the stomach or gut
  • Infections of the ovaries, vagina or womb
  • Skin infections
  • Infections of the membranes surrounding the brain and spinal cord (meningitis)
  • Infections of the blood (septicaemia)
  • High fever and significant reduction in white blood cells resulting decreased resistance to infection (febrile neutropenia)

MEROPENEM RANBAXY is given by injection, usually in hospitals, and is available only with a doctor's prescription.

MEROPENEM RANBAXY is not addictive.

Safety and effectiveness of MEROPENEM RANBAXY in children younger than 3 months of age have not been established. It is not recommended for use in these children.

Ask your doctor if you have any questions about why this medicine has been prescribed for you or your child. Your doctor may have prescribed it for another reason.

Before you are given MEROPENEM RANBAXY

When you must not be given MEROPENEM RANBAXY

Do not take MEROPENEM RANBAXY if you had an allergic reaction before to meropenem, the inactive ingredients listed at the end of this leaflet or other similar antibiotics (e.g. other carbapenems like imipenem; or beta-lactam antibiotics like penicillin, amoxicillin, ampicillin, ceftriaxone, cefotaxime etc).

Symptoms of an allergic reaction may include skin rash, itchiness or hives, shortness of breath, wheezing or difficulty breathing, swelling of the face, tongue, lips or other parts of the body.

If you are not sure whether you should be given MEROPENEM RANBAXY, talk to your doctor.

Before you are given it

Tell your doctor if you have allergies to any other medicines, including any other antibiotics (such as other carbapenems, penicillins, cephalosporins or monobactams)

Tell your doctor if you have allergies to any foods, preservatives or dyes.

Tell your doctor if you have or have had any medical conditions, especially the following:

  • liver or kidney problems, including dialysis
  • disease of the stomach or intestines (in particular inflammation of intestine)

Tell your doctor if you are pregnant or intend to become pregnant, or are breast-feeding. Your doctor will discuss with you the benefits and risks of taking it.

MEROPENEM RANBAXY contains sodium (90mg per 1g of meropenem). Tell your doctor if you are on a controlled sodium diet.

If you have not told your doctor about any of the above tell him/her before you are given MEROPENEM RANBAXY.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines you can buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines and MEROPENEM RANBAXY may interfere with each other. These include:

  • Probenecid (a medicine used to treat gout)
  • Sodium valproate (a medicine used to treat fit/seizure or mania)

These medicines may be affected by MEROPENEM RANBAXY, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking MEROPENEM RANBAXY.

How MEROPENEM RANBAXY is given

MEROPENEM RANBAXY should only be injected into a vein (intravenous injection). It must always be given by a doctor or a nurse. It can be given either as a slow injection over approximately 5 minutes or as a slow drip over 15 to 30 minutes.

Your doctor will decide which is best for you.

How much will you be given

The dose of MEROPENEM RANBAXY is based on your condition, age and type and severity of infection.

Your doctor will decide how much MEROPENEM RANBAXY to give you. The usual dose is 500mg to 1g injected every 8 hours. If you have meningitis you may require more. If you have kidney problems, a smaller dose may be given. Children also require lower doses.

MEROPENEM RANBAXY should not be given to babies less than three months of age or babies and children with kidney problems.

How long will you be given MEROPENEM RANBAXY

MEROPENEM RANBAXY will be given as a number of injections over several days. Your doctor will decide how long you will need to have MEROPENEM RANBAXY.

If you take too much

If you think you have been given too much meropenem, or think that the effect of the medicine is too strong, tell your doctor, nurse or pharmacist immediately.

While you are taking MEROPENEM RANBAXY

Things you must do

Inform your doctor, nurse or pharmacist immediately if you develop severe diarrhoea, even if it occurs several weeks after you have been given MEROPENEM RANBAXY. You may have developed a serious bowel condition called antibiotic-associated colitis and you need urgent medical attention. Do not take any medicine for your diarrhoea without checking with your doctor first.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking MEROPENEM RANBAXY. Like other medicines, MEROPENEM RANBAXY may cause some unwanted side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Tell your doctor or pharmacist if you notice any of the following side effects and they worry you.

These are the more common side effects of meropenem, and are usually mild and short-lived.

  • pain with redness and/or swelling at the site of injection
  • feeling sick (nausea), being sick (vomiting), loose stool (diarrhoea)

Tell your doctor or pharmacist immediately if you notice any of the following:

  • severe diarrhoea, even if it occurs several weeks after you have been given MEROPENEM RANBAXY
  • allergic reactions, including shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue or other parts of the body; skin rash, itchiness or hives.

These are serious side effects. You may need urgent medical attention or hospitalisation. Serious side effects are rare.

Occasionally, meropenem may be related to changes in your blood that may require your doctor to do certain blood tests.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may occur in some patients.

After taking MEROPENEM RANBAXY

Storage

The hospital staff will keep MEROPENEM RANBAXY in a safe place below 25°C. They will also make sure that the expiry date has not passed.

Disposal

The hospital staff will dispose of any unused MEROPENEM RANBAXY.

Product description

What MEROPENEM RANBAXY looks like

MEROPENEM RANBAXY is a sterile white to pale yellow powder supplied in a glass vial. The hospital staff make it up into a solution before injection.

Ingredients

MEROPENEM RANBAXY vials contain either 500 mg or 1g of meropenem (as meropenem trihydrate) as the active ingredient.

The vials also contain sodium carbonate anhydrous as the inactive ingredient.

Sponsor

Sun Pharma ANZ Pty Ltd
12 Waterloo Road
Macquarie Park Sydney NSW
2113 Australia
Tel: 1800 726 229
Email:customerservice.aus@sunpharma.com

Douglas Pharmaceuticals Ltd
P O Box 45 027
Auckland 0651
New Zealand
Phone: (09) 835 0660

Australian Registration Numbers

MEROPENEM RANBAXY powder for injection 500 mg/vial: AUST R 167025

MEROPENEM RANBAXY powder for injection 1 g/vial: AUST R 167024

This leaflet was prepared in October 2021.

Published by MIMS March 2023

BRAND INFORMATION

Brand name

Meropenem Ranbaxy

Active ingredient

Meropenem

Schedule

S4

 

1 Name of Medicine

Meropenem trihydrate.

2 Qualitative and Quantitative Composition

Meropenem powder for injection or infusion is a white to pale yellow crystalline sterile powder for reconstitution. One vial contains meropenem trihydrate equivalent to meropenem 500 mg or 1000 mg. The inactive ingredient sodium carbonate 104 mg or 208 mg respectively.

3 Pharmaceutical Form

Meropenem Ranbaxy is supplied as a sterile lyophilised powder for intravenous infusion available in single dose clear glass vials. The product is a white to pale yellow crystalline powder.

4 Clinical Particulars

4.9 Overdose

The pharmacological properties and mode of administration make it unlikely that intentional overdose will occur. Accidental overdosage could occur during therapy, particularly in patients with renal impairment.
Treatment of overdosage should be symptomatic. In normal individuals, rapid renal elimination will occur. In subjects with renal impairment, haemodialysis will remove meropenem and its metabolite.
For information on the management of overdose, contact the Poison Information Centre on 131126 in Australia.
For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766), in New Zealand.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Meropenem, with and without metabolic activation as appropriate, was not genotoxic in assays for gene mutations (Salmonella typhimurium, E. coli and Chinese hamster ovary cells) and chromosomal damage (mouse micronucleus assay and human lymphocytes in vitro).
Carcinogenicity. The carcinogenic potential of meropenem has not been investigated.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Meropenem is soluble in dimethylformamide and 5% dibasic potassium phosphate solution, sparingly soluble in water and 5% monobasic potassium phosphate solution, practically insoluble in alcohol, acetone and ether. The pH of freshly constituted solutions is between 7.3 and 8.3.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSMEROPE.gif Chemical name: (4R,5S,6S)-3-[[(3S,5S)-5-(dimethylcarbamoyl)-3-pyrrolidinyl]thio]- 6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo- 1-azabicyclo[3.2.0]hept-2-enecarboxylic acid, trihydrate.
CAS number. CAS Number: 119478-56-7.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/MERRBXST.gif